The present invention pertains generally to an implantable microballoon and a method of making such a microballoon.
Implantable microballoons provide a minimally invasive treatment for the urological condition of stress urinary incontinence resulting from Intrinsic Sphincter Deficiency (ISD). Treatment of the condition is completed through placement of one or more implantable balloons into the periurethral tissue of the bladder neck. Implantation of the balloons results in the coaptation of the urethra which improves or resolves the incontinence condition.
Delivery is completed by insertion of the microballoon into the tissue parallel to the urethra. The microballoon is then inflated and left in the bladder neck.
Microballoons can be similarly used for the treatment of vesicoureteral reflux (VUR—reflux of the urine from the bladder up the urethras to the kidneys) and alternative procedures such as embolization or blocking of veins or arteries to accomplish the treatment of enlarged blood vessels in the brain or for treating severe uterine bleeding. Slightly larger balloons may be used for fecal incontinence or gastrointestinal reflux.
Until now, the small size and numerous intricacies of microballoons have presented problems pertaining to performance and manufacture. The valves that are included in such microballoons are typically constructed using numerous parts and designed to be self-sealing once an inflation syringe is removed therefrom. In the assembled condition, an outsidewall of the valve is typically attached to the inside neck of a microballoon using adhesive or similar bonding procedure.
Such a manufacturing method is laborious and expensive. Moreover, when the balloons are inflated, there is a tendency for the adhesive to fatigue, separate and allow the fluid contained within the balloon chamber to leak. Even when the adhesive holds, however, the valve can leak due to manufacturing defects that can result from the complexity and size of the valve.
In view of the above, there is a need for a valve which is simple, reliable and relatively inexpensive. There is also a need for a method of manufacturing a microballoon which is repeatable, efficient, and relatively simple.